NCT06795022 · AstraZeneca
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
(RHEA-1)
What this study is about
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
View original scientific description
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
Interventions
DRUG
AZD9793 Intravenous (IV) monotherapy
T cell-engaging antibody that targets GPC3 on tumour cells
DRUG
AZD9793 Subcutaneous (SC) monotherapy
T cell-engaging antibody that targets GPC3 on tumour cells
Primary outcome measures
The number of patients with adverse events
Time frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events by system organ class and preferred term
The number of patients with serious adverse events
Time frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with serious adverse events by system organ class and preferred term
The number of patients with adverse events of special interest
Time frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events of special interest by system organ class and preferred term
The number of AEs leading to discontinuation of AZD9793
Time frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
Number of AEs that in the opinion of the Investigator or the Sponsor contraindicate further dosing or AEs that meet criteria for discontinuation
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol [Part A Dose Escalation only]
Time frame: From date of first dose of study drug until the end of DLT evaluation period (up to 21, 28 or 35 days depending on dose regimen)
Number of patients with at least 1 DLT. A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of the DLT evaluation period that is assessed as unrelated to the disease or disease-related processes under investigation.
Objective Response Rate (ORR) [Part B Dose Expansion only]
Time frame: From first dose of study drug to progressive disease or the last evaluable assessment in the absence of disease progression whichever comes first (up to approximately 2 years)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 at the time of signing the informed consent.
- GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. Patients who previously received any therapy targeting GPC3 must undergo central laboratory GPC3 testing on tumour tissue collected after completion of the prior GPC3-targeted therapy.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
- Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A.
- Previous therapy: Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per National Comprehensive Cancer Network or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision. Part B: Patients must not have received more than one prior line of systemic therapy in the advanced recurrent and/or metastatic setting. Key
Exclusion criteria
- Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.
- Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.
- CAR-T cell therapy within the last 6 months prior to enrolment on this study.
- Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
- Requires chronic immunosuppressive therapy (including steroids \> 10 mg prednisone/day or equivalent).
- Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted.
- Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing
- Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
- Cardiac conditions as defined by the protocol.
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention.
- Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.
- Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
- Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.
Where
- La Jolla, California
- Los Angeles, California
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- Hackensack, New Jersey
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2026 · Source of record for eligibility and locations